Training Adaptations With and Without Ventilatory Training Device

NCT06356181 | Completed

• 1 other identifier: Pro00135143
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to assess the effectiveness of using a Respiratory Muscle Training (RMT) device during high-intensity functional training (HIFT) to improve fitness and ventilatory parameters. Primary outcome measures include aerobic, anaerobic, and HIFT measures. Secondary measures include sleep, affect, and mood state questionnaires. Participants will be randomized into one of two groups: with the RMT device and without the RMT device.

Conditions

Healthy

Keywords

high-intensity functional training; respiratory training device

Outcome Measures

Primary Outcomes (8)

• Changes in spirometry

  Spirometry measures of forced vital capacity (FVC) (L), forced expiratory volume at one second (FEV1) (L), and the ratio of FEV1/FVC %

  Baseline and Week 8

• Changes in aerobic capacity

  Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.

  Baseline and Week 8

• Changes in peak power

  Assessed via a cycle-ergometer based maximal graded exercise test

  Baseline and Week 8

• Changes in ventilatory threshold

  Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.

  Baseline and Week 8

• Changes in countermovement jump

  Assessed via force plates

  Baseline and Week 8

• Changes in anaerobic capacity

  Assessed via 30-second Wingate test.

  Baseline and Week 8

• Changes in high-intensity functional training test

  Assessed via a high-intensity functional training circuit composed of rows, pushups, and squats

  Baseline and Week 8

• Changes in heart rate at ventilatory threshold

  Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.

  Baseline and Week 8

Secondary Outcomes (6)

• Changes in body composition

  Baseline and Week 8

• Changes in sleep quality

  Baseline and Weeks 3, 5, and 7

• Changes in total mood disturbances

  Baseline and Weeks 3, 5, and 7

• Changes in positive mood and emotion

  Baseline and Weeks 3, 5, and 7

• Change in blood lactate responses

  Weeks 3, 5, and 7

Study Arms (2)

Experimental

EXPERIMENTAL

Participants in this group will undergo 6 weeks of high-intensity functional training using the respiratory muscle training device.

Device: Respiratory Maximus Training Device

Control

ACTIVE COMPARATOR

Participants in this group will undergo 6 weeks of high-intensity functional training without using the respiratory muscle training device.

Device: No Respiratory Training Device

Interventions

Respiratory Maximus Training Device DEVICE

Those in the intervention group will wear the respiratory training device for 3 days per week of high-intensity functional training over 6-weeks.

Experimental

No Respiratory Training Device DEVICE

Those in the control group will train for 3 days per week of high-intensity functional training over 6-weeks.

Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females between the ages of 18 and 35 (inclusive) who participate in at least 150 minutes per week of physical activity.
• Have not participated in HIFT training in the last 6 months.
• Provided written and dated informed consent to participate in the study.
• In good health as determined by medical history and is cleared for exercise.
• Participant will be asked about dietary supplementation use within the past 6 months.
• If participant began taking a supplement within the past month, subject will be asked to discontinue supplement use followed by a 2-week washout prior to participation.
• In all other cases, we will request that participant maintain supplement use.

You may not qualify if:

• Any musculoskeletal injuries that would prevent exercising.
• Any metabolic disorder including known electrolyte abnormalities, diabetes, uncontrolled thyroid disease, adrenal disease or hypogonadism.
• Any inborn error of metabolism.
• History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
• Participants with a personal history of heart disease, high blood pressure (systolic \>140 mm Hg \& diastolic \>90 mm Hg),
• Participants who are pregnant, planning to become pregnant, or lactating.

Sponsors & Collaborators

• University of South Carolina: lead
• MAXIMUS: collaborator

Study Sites (1)

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Exercise Science Department

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 10, 2024
• Study Start: March 18, 2024
• Primary Completion: October 28, 2024
• Study Completion: October 29, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)